Gent, Belgium: December 14 2015 - Fujirebio Europe announces having received the CE mark for its INNOTEST β-AMYLOID(1-40) Alzheimer test, an immunoassay kit for the quantification of β-Amyloid(1-40) in cerebrospinal fluid. With its CE version this marker can now be used for in vitro diagnostics in combination with the existing range of INNOTESTAlzheimer biomarkers for routine testing (Aβ1-42, total Tau, and p-Tau181P).
“During the last decade Fujirebio has, under the name Innogenetics, been on the very forefront in the fight against neurodegeneration”, said Christiaan De Wilde, CEO of Fujirebio Europe. “We continue to invest important time and resources to support our gold standard INNOTEST ELISA microplate panel of biomarkers in parallel with an ongoing development for the fully automated LUMIPULSE® platforms. We have a strong commitment and work actively with worldwide consortia for a global standardization of these Alzheimer biomarkers.”
The CE marked INNOTEST β-AMYLOID(1-40) kit offers the same features as the 3 classic INNOTEST Alzheimer biomarkers. The new kit also offers an improved indication of the total amyloid production in the brain and can therefore be used to adjust for inter-individual variation in amyloid production in patients with indeterminate biomarker profiles based on the three most commonly used CSF biomarkers1,2.
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About Alzheimer’s disease (AD)
Alzheimer’s disease (AD) is a widespread condition that occurs in 50% to 60% of individuals suffering from dementia. Globally, it is one of the most disabling and burdensome of health conditions and its incidence is rising rapidly due to increasing life expectancy. From the age of 65 the incidence of AD doubles every five years (from around 2-3% at age 65 to no less than 35-40% after 85 years of age). This public health care issue translates into millions of people suffering from the condition Worldwide today. The number is estimated to nearly double every 20 years set to reach 74.7 million in 2030, surging to 131.5 million in 20503.
The challenge of early, accurate diagnosis
Alzheimer’s disease starts silently, and develops several years before clinical symptoms appear. Until recently, it has been difficult for physicians to predict which individuals with memory problems will eventually develop AD, and which ones will not. Even when clinical symptoms of dementia are present, the clinical diagnosis of AD is reported to be correct in only 65% to 96% of the time4. Accuracy rates tend to be especially low in the earlier stages of AD. This has led to an ‘accuracy gap’. New diagnostic tools to help detect AD as early as possible, and make early diagnosis with the highest level of certainty are of fundamental importance for both physicians and the families involved. This is because memory complaints can result from several causes and may be reversible. In its early stages, it is especially difficult to discriminate AD from depression, or even normal aging.
Another reason that early detection tools are urgently needed is because it is believed that the treatment of diseases such as AD ideally should begin as soon as possible. Pharmaceutical companies trying to develop new AD treatments need reliable tests to establish clear-cut treatment groups, and means of monitoring the effectiveness of candidate treatments. CSF markers could be used to stratify patients for tailor-made allotment of therapies.5
Fujirebio is a leading international healthcare company with a strong focus on high quality in vitro diagnostics (IVD) testing solutions. Founded more than 60 years ago in Japan, the company is today recognized as the world-wide market leader in oncology for both routine and novel markers and has a strong reputation in Japan in infectious disease testing in hospitals, clinical labs and blood banks. Fujirebio launched the World’s first biomarker for early detection of Alzheimer’s Disease in 1995 and remains the best-in-class standard for neurodegeneration testing. Over the last 20 years Fujirebio has been committed to bringing solid and successful automated immunoassay testing solutions and state of the art chemiluminescent assay products to the market. The company has also been pioneering the field of molecular diagnostics and multiparameter testing and it is today one of the world leaders in strip-based diagnostics solutions.
The product lines range from specialized manual testing to fully automated routine testing and they cover disease fields such as infectious, oncology, genetic testing, thyroid, fertility, tissue typing, neurodegeneration and bone.
Fujirebio is a subsidiary of Japan-based Miraca Holdings (listed in the Tokyo Stock Exchange - MRCHF) and counts more than 1.100 employees working in Asia, Europe and America, including subsidiaries. For more information about Fujirebio please visit www.fujirebio.com/english or www.fujirebio-europe.com.